Enzalutamide in Patients With High-risk Prostate Cancer
|ClinicalTrials.gov Identifier: NCT01927627|
Recruitment Status : Active, not recruiting
First Posted : August 22, 2013
Last Update Posted : June 12, 2017
The purpose of this study is to see how long it takes for prostate cancer to come back in patients who have had surgery to remove their prostate gland (radical prostatectomy), while being treated with enzalutamide (formerly known as MDV3100).
Enzalutamide is known as an androgen-receptor signaling inhibitor, which means that it blocks activity of the male hormone, testosterone. Most prostate cancers are dependent on testosterone for growth. In this study, patients will take enzalutamide after surgery to see if it keeps their cancer from coming back.
|Condition or disease||Intervention/treatment||Phase|
|Adenocarcinoma of the Prostate||Drug: enzalutamide||Phase 2|
This is a pilot phase II study evaluating the clinical activity and safety of Enzalutamide (formerly known as MDV3100) a novel androgen receptor (AR) inhibitor in men with high-risk prostate cancer who have undergone local definitive therapy with radical prostatectomy.
-To evaluate the clinical efficacy of enzalutamide in patients with high-risk prostate cancer with regards to: Time to disease progression defined by biochemical recurrence (BCR)
-To further evaluate the safety of enzalutamide in patients with high-risk prostate cancer
Patients will receive daily oral therapy with enzalutamide at 160mg (4 capsules) orally once daily (QD). Patients will continue on study until progressive disease, drug intolerability, consent withdrawal or completion of study at 24 months.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||42 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 2 Study of Enzalutamide in Patients With High-risk Prostate Cancer Who Have Undergone Local Definitive Therapy With Radical Prostatectomy|
|Actual Study Start Date :||November 11, 2013|
|Primary Completion Date :||March 29, 2017|
|Estimated Study Completion Date :||March 2019|
Oral therapy with enzalutamide at 160mg (4 capsules) orally once daily (QD).
oral therapy with enzalutamide at 160mg (4 capsules) orally once daily (QD).
- Time to progression, defined by serologic criteria. [ Time Frame: 2 years ]Serologic criteria is a PSA value > 0.4 in two separate occasions at least two weeks apart.
- Safety of enzalutamide [ Time Frame: 2 years ]To further evaluate the number of patients that experience adverse events related to the study drug. NCI Cancer Clinical Trials Common Toxicity Criteria (version 4.0)will be utilized.
- Impact of enzalutamide on circulating tumor cells (CTCs) [ Time Frame: 2 years ]Quantify mRNA levels of Survivin in CTCs obtained from patients pre- and post-treatment with enzalutamide using the Veridex Cell Search Profile kit.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01927627
|United States, Ohio|
|Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center|
|Cleveland, Ohio, United States, 44195|
|Principal Investigator:||Jorge Garcia, MD||Case Comprehensive Cancer Center|